t:slim X2™ Insulin Pump Now Available with Abbott’s FreeStyle Libre® 3 Plus Sensor in the United States
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The t:slim X2™ Insulin Pump with Abbott’s FreeStyle Libre® 3 Plus Sensor is now available in
“With this integration, we expand the benefits of greater control to more people living with diabetes worldwide with our AID system that is easy to start, use, and personalize,” said
The FreeStyle Libre 3 Plus sensor is the world’s smallest CGM available today.1 It transmits automatic glucose readings every minute directly to the pump and offers an extended 15-day wear time. Control-IQ+ technology is Tandem's newest advanced hybrid closed-loop algorithm, which adjusts insulin every five minutes based on predicted glucose values. It is also the only system featuring AutoBolus,‡ which automatically calculates and delivers a correction bolus, helping reduce the impact of missed meal boluses and easing the day-to-day burden of diabetes management.
Tandem will email all eligible t:slim X2 users in
To learn more about this integration in
Early access recruitment and communication about commercial availability in additional countries will be addressed in each region.
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* CGM sold separately
† Software updates may not be offered everywhere and would be subject to applicable regulatory approvals. Charges may apply.
‡ If glucose values are predicted to be above 180 mg/dL (or 10.0 mmol/L), Control-IQ+ calculates an AutoBolus using the Personal Profile settings and a target of 110 mg/dL (or 6.1 mmol/L) and delivers 60% of that value.
Reference
1. Among patient-applied sensors. Data on file.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, our ability to provide the software update for current t:slim X2 pump users and the t:slim X2 pumps pre-loaded with Freestyle Libre 3 Plus sensor integration software. These statements are subject to numerous risks and uncertainties, including our ability to sustain commercial scale manufacturing of the t:slim X2 pumps pre-loaded with Freestyle Libre 3 Plus sensor integration software, our ability to operate and maintain a system to facilitate online training for existing t:slim X2 pump customers upgrading their existing devices, and the risk that we may encounter other challenges that may delay the availability of the software update for current t:slim X2 pump users or the t:slim X2 pumps pre-loaded with Freestyle Libre 3 Plus sensor integration software. These and other risks are identified and described in greater detail under the “Risk Factors” heading of our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other documents filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Actual results could differ materially from those anticipated or projected in the forward-looking statements. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events, or other factors.
Important Safety Information – FreeStyle Libre Systems
Product for prescription only; for Important Safety Information, please visit FreeStyleLibre.us.
Important Safety Information –
RX ONLY. The t:slim X2 pump with interoperable technology (the pump) and Control-IQ+ technology (Control-IQ+) are intended for single patient use. The pump and Control-IQ+ are indicated for use with NovoLog or Humalog U-100 insulin. t:slim X2 insulin pump: The pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is indicated for use in persons 2 years of age and greater. Control-IQ+ technology: Control-IQ+ technology is intended for use with compatible integrated continuous glucose monitors (iCGM, sold separately) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater.
WARNING: Control-IQ+ should not be used in anyone under the age of 2 years old with Type 1 diabetes or under the age of 18 years old with Type 2 diabetes. It should also not be used in patients who require less than a total daily insulin dose of 5 units of insulin per day or who weigh less than 20 pounds (9 kilograms), as those are the required minimum values needed for Control-IQ+ to operate safely.
Users of the pump and Control-IQ+ must: use the insulin pump, iCGM, and all other system components in accordance with their respective instructions for use. Failure to follow these instructions for use could result in an over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events. Visit tandemdiabetes.com/safetyinfo for additional important safety information.
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